Remibrutinib

China-based LongBio Pharma (Suzhou) Co., Ltd announced positive topline results from a Phase II trial of LP-003, its next-generation anti-IgE antibody, in patients with chronic spontaneous urticaria (CSU) who remained symptomatic despite H1 antihistamine treatment. The data, presented as a late-breaking poster at the 2026 AAAAI Annual Meeting, showed LP-003 achieved statistically superior outcomes compared with omalizumab (Xolair) across two key efficacy endpoints — a result that, if confirmed in Phase III, could position the molecule as the first new anti-IgE therapy to reach the market in more than two decades. The trial (NCT06228560, CTR20233300) was a multicenter, randomized, double-blind, placebo- and active-controlled study conducted in China. A total of 202 adults with CSU were enrolled and assigned to one of five arms: LP-003 at 100 mg every four weeks (Q4W), LP-003 200 mg Q4W, LP-003 200 mg every eight weeks (Q8W), omalizumab 300 mg Q4W, or placebo. The treatment duration was 24 weeks. The primary endpoint was the proportion of patients achieving a weekly Urticaria Activity Score of zero (UAS7=0) — denoting complete absence of hives and itch — at Week 12, with the top rate of 66.7% achieved in the LP-003 200 mg Q8W arm, and 57.5% in the LP-003 200 mg Q4W arm, versus 43.6% in the omalizumab arm, and 10.8% in the placebo arm. The comparison between LP-003 200 mg Q8W and omalizumab reached statistical significance (p=0.0405). A second key efficacy measure, the least-squares mean change from baseline in UAS7 at Week 12, was −26.63 for LP-003 200 mg Q8W versus −21.85 for omalizumab (p=0.0137). By Week 4, complete remission rates across LP-003 groups ranged from 35% to 35.9%, suggesting a fast onset of action relative to the comparator. LongBio described the safety profile as favorable, though no quantitative adverse-event data were disclosed in the topline release. The company said a Phase III trial for CSU in China is expected to begin in H1 2026. Separately, LP-003’s lead indication is seasonal allergic rhinitis (SAR), for which a Phase III trial in China has completed enrollment and a Biologics License Application (BLA) submission to China’s National Medical Products Administration (NMPA) is planned in or before Q3 2026. If approved, LP-003 would become the first and only innovative anti-IgE drug to be launched globally in over 20 years since the approval of omalizumab. LP-003 is a monoclonal antibody that neutralizes free immunoglobulin E (IgE), the same target as omalizumab. By binding circulating IgE, the antibody prevents it from engaging the high-affinity IgE receptor FcεRI on mast cells and basophils, reducing degranulation and the downstream release of histamine and other mediators that drive wheals and pruritus. Over time, anti-IgE therapy also downregulates FcεRI surface expression, further dampening the allergic cascade. LongBio states that LP-003 has 860-fold greater IgE binding affinity and 30-fold higher blocking activity than omalizumab, along with a longer half-life. The CSU treatment landscape has evolved in the past two years. Key competing assets include: Novartis’s remibrutinib (LOU064), an oral Bruton’s tyrosine kinase (BTK) inhibitor that has completed Phase III trials in CSU and received a positive CHMP opinion for EU approval. Remibrutinib acts downstream of IgE signaling, inhibiting mast cell and basophil activation directly, and represents a mechanistically distinct oral alternative. Sanofi/Regeneron’s dupilumab (Dupixent), an IL-4 receptor alpha antibody already approved for multiple type 2 inflammatory conditions, which has received a positive CHMP recommendation for CSU in children aged 2–11 years and is being studied in broader CSU populations. United BioPharma’s UB-221, another anti-IgE monoclonal antibody in Phase II for CSU, which targets IgE with a reported CD23-mediated IgE downregulation mechanism. Novartis’s ligelizumab (QGE031), a high-affinity anti-IgE antibody that completed Phase III in CSU but whose development extension was terminated, leaving its forward trajectory in this indication unclear.

Dive Brief:Roches experimental pill fenebrutinib hit its main goal in a second Phase 3 trial in the most common form of multiple sclerosis, helping treatment recipients experience significantly fewer relapses than study volunteers who got Sanofis Aubagio, the company said Monday.However, Roche also reported a case of severe liver side effects in one enrollee who got fenebrutinib in the study. It also revealed a higher number of deaths among people who took its therapy in the two Phase 3 trials in relapsing MS, which prompted one analyst, Michael Leuchten of Jefferies, to question the drugs approval prospects. Analysts have forecasted peak sales of more than 3 billion Swiss francs, or $3.8 billion,for fenebrutinib, Leuchten wrote.Fenebrutinib is part of a new crop of BTK inhibitors that drugmakers are now positioning as potential autoimmune disease treatments. The effort has yielded multiple setbacks in MS, though, as the Food and Drug Administration recently rejected a BTK drug from Sanofi, and other developers like Merck KGaA and Biogen have given upon prospective drugs.Dive Insight:BTK, or Brutons tyrosine kinase inhibitors, have proven successful at treating blood cancers like leukemia and lymphoma. But theyve been seen as helping with autoimmune conditions, too, as they work by suppressing the activity of the B cells that go haywire in those diseases. Other B cell-targeting therapies, like Roches Ocrevus and Novartis Kesimpta,have helped people with MS control relapses and disability progression.Some BTK drugs have already made inroads against immunological disorders. Sanofis Wayrilz and Novartis Rhapsido have been approved in immune thrombocytopenia and a form of hives, respectively. But progress has been slower-going against MS. Sanofi appeared poised to bring its drug, tolebrutinib, to market for a less common form of the disease. But the rejection it received was based around the kind of liver concernsthat now hang over fenebrutinib.Roche reported Monday that in a trial called FENhance 1, people with the relapsing form of the disorder who got fenebrutinib had a 51% lower yearly relapse rate than those who got Aubagio over the course of at least 96 weeks. That result was consistent with findings from an earlier trial in relapsed disease, FENhance 2. Roche said the combined results equate to approximately one relapse every 17 years. The drug also succeeded in another study in primary progressive disease.However, in FENhance 1, Roche said there was one case in the fenebrutinib group, along with one in the Aubagio group, of liver enzyme elevations that met a threshold called Hys law.That threshold equates to an increased risk of death or liver transplantation, and often draws attention from U.S. drug regulators.Additionally, in the combined FENhance 1 and 2 populations, there were eight deaths among fenebrutinibrecipients with various causes and at different points in treatment, compared with one in Aubagio-treated patients. Further analyses are ongoing to better understand these findings, Roche said in a statement.The new findings, then, may not help fenebrutinibs already shaky case to the Food and Drug Administration, Leuchten wrote in a note to clients. Liver-related side effects were already a known issue from earlier fenebrutinib studies as well as trials of other BTK inhibitors. But the imbalance in patient deaths is a new finding that will likely stimulate further scrutiny, he wrote.The tolebrutinib[rejection letter] makes clear the FDA is looking at a risk/balance profile especially if treatment alternatives are available, he wrote. Combined with the liver safety we are not sure the fenebrutinib profile clears the bar. '